MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter associated with this complaint was not returned for evaluation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
The icy catheter (lot # unknown) was inserted into the right femoral vein by the trauma resident.The post-arrest patient was in the normothermia phase when the air trap messaged alarmed.There were no traces of fluid observed around the start-up kit (suk) tubing, the floor, or the bed.The suk air trap and the holder were dry.The user observed the 1000ml saline bag to be almost empty.The console was paused for troubleshooting the leak.The customer was instructed to test the catheter for the leak.The catheter was tested with the syringe with sterile saline and the presence of a blood tinge was noted in the catheter in luer tubing.A catheter leak and the infusion of 500ml of saline fluid were suspected.The icy catheter was not replaced as the patient was at the end of the treatment.Per the reporter, the console is functional and ready for clinical use.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot # 171595) was confirmed during functional testing.A bonding leak was observed at the proximal end of the medial balloon during the functional pressure leak test.The probable root cause could be a latent defect at the bond.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Blood residues were observed in the distal luered tubing.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100psi, a bonding leak was observed at the proximal end of the medial balloon, thus confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for a quattro catheter with lot number 171595.
Event or Problem Description
The icy catheter (lot # 171595) was inserted into the right femoral vein by the trauma resident.The post-arrest patient was in the normothermia phase when the air trap messaged alarmed.There were no traces of fluid observed around the start-up kit (suk) tubing, the floor, or the bed.The suk air trap and the holder were dry.The user observed the 1000ml saline bag to be almost empty.The console was paused for troubleshooting the leak.The customer was instructed to test the catheter for the leak.The catheter was tested with the syringe with sterile saline and the presence of a blood tinge was noted in the catheter in luer tubing.A catheter leak and the infusion of 500ml of saline fluid were suspected.The icy catheter was not replaced as the patient was at the end of the treatment.Per the reporter, the console is functional and ready for clinical use.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15181711
• Report Number: 3010617000-2022-01081
• Device Sequence Number: 6390329
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 171595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown